Community Engagement for Cardiovascular Health Promotion in Mothers (MomHeartHealth2.0)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Feasibility: Program Completion
研究概览
简要总结
This project will test the feasibility, acceptability, and preliminary effects of a tailored cardiovascular (CV) health promotion program, Mom♥Health2.0, leveraging childcare centers as platforms for maternal engagement. Investigators will enroll 50 mothers from Childcare Centers in New York City.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female adults, age 18-49 years.
- •Mothers, self-identified as primary caregivers of children ≤ 5 years (biological, adopted, fostered) whose child(ren) attend formal childcare (no home daycare);
- •English or Spanish speaking.
- •Willing and able to consent to participation.
排除标准
- •Significant cognitive impairment (evident during screening)
- •Current participation in another behavioral clinical trial
结局指标
主要结局
Feasibility: Program Completion
时间窗: Up to Week 10 (End of Intervention)
Feasibility is measured as the number of participants with 80% participant program completion.
Feasibility: Appointment Scheduling
时间窗: Up to Week 18 (End of Study)
Feasibility is measured as the number of participants with 80% clinic/social services appointment scheduled for identified needs
Acceptability: Consent Rate
时间窗: Baseline
Acceptability is measured as the consent rate of eligible mothers; the aim is 80%.
Acceptability: Client Satisfaction
时间窗: Week 18 (End of Study)
Acceptability is measured as the number of participants with an average post-intervention Client Satisfaction Questionnaire-8 score ≥ 25. The questionnaire comprises 8-items and assesses program satisfaction in: quality, whether it has met individual needs, if the individual would recommend to others. The total range is 8-32; a score of 25 is an established cutoff for good satisfaction.
次要结局
- Change in Life's Essential Eight Score(Baseline, Week 18 (End of Study))
- Change in Perceived Stress Scale (PSS-4) Score(Baseline, Week 18 (End of Study))
- Change in Patient Health Questionnaire (PHQ-8) Score(Baseline, Week 18 (End of Study))